Status:
Recruiting
Disease Site:
Heme
Diagnosis:
- Multiple Myeloma
Phase:
Official Title:
Phase III Study of Daratumumab/rHuPH20 (NSC-810307)+Lenalidomide or Lenalidomide as Post-Autologous Stem Cell Transplant Maintenance Therapy in Patients with Multiple Myeloma (MM) Using Minimal Residual Disease to Direct Therapy Duration (DRAMMATIC Study)
NCT ID:
NCT#04071457
Link to Full Details:
Investigators:
- Dr. Mark Olsen
Description:
Patients are enrolled to screening (Reg Step 1) prior to or after ASCT but prior to Reg Step 2. Patients are followed until they will begin Maintenance and then registered to Reg Step 2 (first randomization). Patients are randomized between Lenalidomide for 2 years and Lenalidomide + Daratumumab/rHuPH20. After 2 years of Maintenance, MRD is assessed to guide further therapy. MRD-positive patients will continue with the assigned treatment. MRD-negative patients will be further randomized (Reg Step 3) to either continue or discontinue the assigned treatment. Patients are treated for up to 7 years from Step 2 reg and followed for up to 15 years.
Eligibility:
Male and Female – 18 years and older
Inclusion Criteria:
- Diagnosis of symptomatic MM that required systemic induction therapy prior to autologous stem cell transplantation
- Disease measurable by light chain alone are eligible
- Performance status < 2
Exclusion Criteria:
- Smoldering myeloma
- Organ involvement by amyloidosis
- Progressive disease